PRISYM ID Blog How can a clinical labeling solution translate to results in the agile era?

Complexity around the management of labeling for clinical trials is not a new phenomenon, especially when you consider the need for most research to be done on a global scale - aligning not only to local language languages, but also local regulations and processes. In recent years, however, we have seen a surge in demand for supporting organizations capable of delivering agile clinical trials for all therapies in development so that drugs and devices can get to market faster and maximize earnings before patent expiration. An agile approach requires each stage of the clinical trial supply chain to function at speed, including label and booklet production. However, the requirement for localized labels with translated content is a significant logistical hurdle and can result in a bottleneck as translations are often the lengthiest part of the entire process when accounting for the use of translation houses alongside internal reviews. Barriers to the production of clinical trial labels and booklets at speed Agile clinical trial models tend to involve accelerated decision-making, parallelization of processes and changes to trial protocols at an unprecedented frequency. Consequently, labels and booklets need to be produced almost on-demand to reflect the latest changes. This is no easy feat for several reasons. Firstly, country-specific requirements mean clinical trial labels require localization to account for the different regulatory requirements, especially those relating to languages. When running a trial across many different countries, this means accounting for multiple official languages and numerous regional dialects to ensure compliance and understanding from patients. Furthermore, target countries are subject to change at short notice due to the availability of eligible patients, meaning the supply chain for any clinical trial needs to be able to quickly adjust and accommodate new regulatory and language requirements. Secondly, sponsors are moving away from the global hub model and increasingly introducing regional hubs to speed up delivery to trial sites while improving supply chain resiliency. The use of multiple distribution sites can introduce inefficiencies and additional risk unless robust systems and processes are put in place to minimize the duplication of effort and avoid inconsistencies in translations. Finally, the management of multiple assets also poses challenges as there must be complete consistency of translated phrases used throughout a trial. In addition, after the contents have been translated and/or other country-specific requirements are fulfilled, booklet and label designs suitable for one country may not be suitable for another due to available space for content. Finding a solution To effectively address these challenges, organizations require a clinical trials labeling solution and accompanying systems based on GxP (Good x Practice) compliance. The overall goal is the establishment of an end-to-end controlled and approvals-based process - from label and booklet design, data integration to print and finally label inspection - eliminating the potential for error. A cloud-based system is the most logical choice for organizations operating regional hubs, facilitating the sharing of critical data and helping to minimize the duplication of effort. It will integrate specialist functionality including translation management tools and The post How can a clinical labeling solution translate to results in the agile era? first appeared on PRISYM ID.